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Product NDC Code | 11822-5158 | ||||
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Drug Name | Sinus congestion and pain |
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Type | Brand | ||||
Pharm Class | Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], alpha-1 Adrenergic Agonist [EPC] |
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Active Ingredients |
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Route | ORAL | ||||
Dosage Form | TABLET, FILM COATED | ||||
RxCUI drug identifier | 1369775 | ||||
Application Number | ANDA203200 | ||||
Labeler Name | Rite Aid Corporation | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each tablet) Ibuprofen 200 mg (NSAID)* Phenylephrine HCl 10 mg *nonsteroidal anti-inflammatory drug
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions • do not take more than directed • adults and children 12 years of age and over: • take 1 tablet every 4 hours while symptoms persist. • do not use more than 6 tablets in any 24-hour period unless directed by a doctor • children under 12 years of age: do not use because this product contains too much medication for children under this age
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, stearic acid, sucralose, talc, titanium dioxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses • temporarily relieves these symptoms associated with the common cold or flu: • headache • fever • sinus pressure • nasal congestion • minor body aches and pains • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose
Purpose
Information about the drug product’s indications for use.Purposes Pain reliever/fever reducer Nasal decongestant
Spl product data elements
Usually a list of ingredients in a drug product.sinus congestion and pain Ibuprofen, phenylephrine hydrochloride IBUPROFEN IBUPROFEN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE ACESULFAME POTASSIUM SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 FD&C YELLOW NO. 6 FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED STEARIC ACID SUCRALOSE TALC TITANIUM DIOXIDE brownish-orange L158
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel FREE FROM | GLUTEN FREE Compare to the active ingredients of Advil ® Sinus Congestion & Pain NON-DROWSY SINUS CONGESTION & PAIN IBUPROFEN 200 mg/PHENYLEPHRINE HYDROCHLORIDE 10 mg TABLETS PAIN RELIEVER/FEVER REDUCER (NASAID) & NASAL DECONGESTANT ACTUAL SIZE Relief of: nasal congestion, headache, sinus pressure, fever, nasal swelling, body aches 20 COATED TABLETS sinus congestion and pain-image
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke • you are taking a diuretic
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking any other product that contains phenylephrine or any other nasal decongestant • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use • in children under 12 years of age because this product contains too much medication for children under this age • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-719-9260
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • pain gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • nasal congestion lasts for more than 7 days • symptoms continue or get worse • redness or swelling is present in the painful area • you get nervous, dizzy, or sleepless • any new symptoms appear
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product • take with food or milk if stomach upset occurs
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Storage and handling
Information about safe storage and handling of the drug product.Other information • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F). • read all warnings and directions before use. Keep carton.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • facial swelling • asthma (wheezing) • shock • skin reddening • rash • blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you: • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Do not use • in children under 12 years of age because this product contains too much medication for children under this age • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product Ask a doctor before use if • stomach bleeding warning applies to you • you have problems or serious side effects from taking pain relievers or fever reducers • you have a history of stomach problems, such as heartburn • you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke • you are taking a diuretic Ask a doctor or pharmacist before use if you are • under a doctor’s care for any serious condition • taking any other product that contains phenylephrine or any other nasal decongestant • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • taking any other drug When using this product • take with food or milk if stomach upset occurs Stop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of body • slurred speech • leg swelling • pain gets worse or lasts more than 7 days • fever gets worse or lasts more than 3 days • nasal congestion lasts for more than 7 days • symptoms continue or get worse • redness or swelling is present in the painful area • you get nervous, dizzy, or sleepless • any new symptoms appear If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API